Department of Thoracic Surgery, West China Hospital, Sichuan University, No. 37, Guoxue Alley, Chengdu, 610041, Sichuan, China.
West China School of Medicine, Sichuan University, No. 37, Guoxue Alley, Chengdu, 610041, Sichuan, China.
Trials. 2020 Feb 27;21(1):232. doi: 10.1186/s13063-020-4146-1.
Pleural lavage is regularly performed before closing the chest wall in pulmonary surgeries to prevent pleural implantation of tumor cells and postoperative infection. However, scant data could be found in the literature regarding the optimal regimen for performing pleural lavage. To establish a proper volume of pleural lavage, we herein designed a protocol for a randomized controlled trial.
A total of 400 participants with non-small cell lung cancer undergoing video-assisted thoracoscopic surgery (VATS) lobectomy and systematic mediastinal lymph node dissection (MLND) will be randomly assigned to one of two groups: group A (500 mL pleural lavage fluid) and group B (3000 mL pleural lavage fluid). The primary outcomes include the levels of leukocytes, neutrophils, and inflammatory factors on the first postoperative day. The secondary outcomes include (i) the levels of leukocytes, neutrophils, and inflammatory factors on the second and third postoperative days; (ii) the incidence of postoperative fever on the first, second, and third postoperative days; (iii) the volumes of chest drainage within the first 3 operative days, the duration of drainage, and postoperative hospitalization; and (iv) the incidence of postoperative complications (incision infection, pain, atelectasis, hemorrhage, etc.) and the incidence of pleural effusion requiring thoracic puncture or drainage within 30 days after surgery. The main content of the analysis includes effectiveness and safety analysis. We will perform subgroup analyses to identify potential influence factors.
As far as we know, this will be the first randomized controlled trial to compare the clinical outcomes between different volumes of pleural lavage fluid following VATS and MLND. Findings from this trial will determine the appropriate amount of pleural lavage before chest wall closure.
This study was registered with the Chinese Clinical Trial Registry ( on 17 March 2019. ChiCTR 1900021950).
在肺外科手术中，关闭胸壁前通常会进行胸腔灌洗，以防止肿瘤细胞胸膜种植和术后感染。然而，文献中关于胸腔灌洗最佳方案的数据很少。为了确定适当的胸腔灌洗量，我们设计了一项随机对照试验方案。
共 400 名接受电视辅助胸腔镜手术（VATS）肺叶切除术和系统纵隔淋巴结清扫术（MLND）的非小细胞肺癌患者将被随机分为两组：A 组（500ml 胸腔灌洗液）和 B 组（3000ml 胸腔灌洗液）。主要结局包括术后第 1 天白细胞、中性粒细胞和炎症因子的水平。次要结局包括：（i）术后第 2 天和第 3 天白细胞、中性粒细胞和炎症因子的水平；（ii）术后第 1、2 和 3 天发热的发生率；（iii）术后第 1 至 3 天胸腔引流的量、引流时间和术后住院时间；（iv）术后并发症（切口感染、疼痛、肺不张、出血等）的发生率以及术后 30 天内需要胸腔穿刺或引流的胸腔积液发生率。主要内容的分析包括有效性和安全性分析。我们将进行亚组分析，以确定潜在的影响因素。
据我们所知，这将是首次比较 VATS 和 MLND 后不同量胸腔灌洗液对临床结局的影响的随机对照试验。该试验的结果将确定关闭胸壁前胸腔灌洗的适当量。
本研究于 2019 年 3 月 17 日在中国临床试验注册中心（ChiCTR1900021950）注册。ChiCTR1900021950
